Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT01208805
Status:
UNKNOWN
Last Update Posted:
2010-09-24
First Post:
2010-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-23', 'studyFirstSubmitDate': '2010-09-23', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.']}, 'descriptionModule': {'briefSummary': 'The study first aim is to investigate the relationship between different patterns of electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to optimize spinal cord stimulation parameters . The second aim of the study is to investigate the role of the spinal cord in some aspects of cognitive-sensory-motor processing, specifically the presence of top-down attentional effects on the sensory analysis of an external stimulus at the spinal cord level.\n\nThe study will be performed on patients that will be implanted with a spinal epidural electrode because of chronic intractable pain. From these electrodes, spinal cord evoked potentials (SCEPs) will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with epidural elektrodes for intractable pain (spinal cord stimulation)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 - 70\n* Candidates for spinal cord stimulation\n* Epidural electrode at the the level of the cervical or thoracic spine.\n\nExclusion Criteria:\n\n* Generalized sensory deficit interfering with the recording of spinal cord evoked potentials'}, 'identificationModule': {'nctId': 'NCT01208805', 'acronym': 'SCEPTISM', 'briefTitle': 'Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Spinal Cord Evoked Potentials in Candidates for Dorsal Column Stimulation', 'orgStudyIdInfo': {'id': 'S52573'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Candidates for dorsal column stimulation', 'interventionNames': ['Behavioral: Recording spinal cord evoked potentials']}], 'interventions': [{'name': 'Recording spinal cord evoked potentials', 'type': 'BEHAVIORAL', 'description': 'Recording spinal cord evoked potentials from patients suffering from intractable pain in whom epidural electrodes have already been implanted', 'armGroupLabels': ['Candidates for dorsal column stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Brabant', 'country': 'Belgium', 'contacts': [{'name': 'An Hendriks', 'role': 'CONTACT', 'email': 'an.hendriks@uzleuven.be', 'phone': '+32 16 34 19 98'}, {'name': 'Bart Nuttin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Tom Theys, MD', 'role': 'CONTACT', 'email': 'tom.theys@uzleuven.be', 'phone': '+32 16 344290'}, {'name': 'Bart Nuttin, MD PhD', 'role': 'CONTACT', 'email': 'bart.nuttin@uzleuven.be', 'phone': '+32 16 344290'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Bart Nuttin', 'oldOrganization': 'UZ Leuven'}}}}